In addition, skin elasticity may be measured at the treatment areas at baseline and follow-up visits. The circumference of the area to be treated will be measured with a tape measure, weight/height will be recorded and the Body Mass Index (BMI) will be calculated at baseline and follow-up visits. Ultrasound may be taken at baseline and at the follow-up visits to evaluate flatness of cellulite and dermal fibrosis or enlargement of the reticular dermis. Photographic equipment and the protocol for photography will be consistent at each visit. A comparison of baseline photographs (prior to treatments) to photographs taken 1 and 3 months after the completion of treatments will be conducted. The contra-lateral side will not be treated and will serve as a control. Treatment will be conducted on either the left or the right thigh, which will be randomly determined. The secondary objective is to assess the safety and efficacy of the laser with cooling and the laser without cooling for improvement in appearance of cellulite.
The primary objective is to assess the safety and efficacy of the laser for improvement in appearance of cellulite.Treatment areas will be limited to the thighs. The objective of this investigation is to evaluate the effectiveness of a non-ablative treatment for skin laxity by increasing dermatofibrosis of the reticular dermis using the Candela GentleYAG laser. Why Should I Register and Submit Results?.
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